Senior Quality Manager CMO - Monoclonal Antibody Manufacturing | Biotechnologist (m/w/d)

Job Summary

As a Senior Quality Manager for Contract Manufacturing Organizations (CMOs), you will serve as the primary quality contact for external partners producing oncology products. Your day-to-day responsibilities involve managing quality oversight, implementing GMP/GDP standards, and handling critical quality processes such as change control, deviations, and complaints. You will be responsible for defining and tracking CAPAs, reviewing APQRs and validation reports, and negotiating Quality Assurance Agreements (QAAs). A significant part of the role involves acting as a subject matter expert during site transfers, manufacturing process establishments, and authority inspections. This position is highly collaborative, requiring you to interface with global teams in Supply Chain, CMC, and Regulatory departments to ensure consistent product supply. What makes this role unique is the opportunity to influence the global quality management system of a major pharmaceutical company while overseeing complex monoclonal antibody manufacturing processes. You will play a vital role in identifying quality risks and driving continuous improvement across the global SOP landscape.